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GI-101 + lenvatinib
- Development stage
- Phase 2
- Lead developer
- GI Innovation
- Modality
- T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Small Molecules
- Administration
- Intravenous (GI-101), Oral (lenvatinib)
01
Overview
GI-101 + lenvatinib is an investigational **combination therapy** for advanced and metastatic solid tumors. GI-101 is a novel bispecific Fc fusion protein engineered to contain the CD80 ectodomain at its N-terminus and an interleukin-2 variant (IL-2v) at its C-terminus, linked via a human IgG4 Fc region. This molecule is designed to enhance cancer-specific immune responses through dual mechanisms: it activates and proliferates effector T cells and NK cells, while counteracting immunosuppression by inhibiting regulatory T cell (Treg) function within the tumor microenvironment. Lenvatinib is an approved oral small molecule that inhibits multiple tyrosine kinases, notably vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptors (FGFR), leading to reduced tumor angiogenesis and cell proliferation. The combination is under clinical investigation for its ability to potentiate anti-tumor efficacy by targeting both tumor cell signaling and the immune response.
- Brand names
- Lenvima (lenvatinib)
- Other names
- GI-101 + lenvatinib
02
Targets
CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)FGFR1 (Fibroblast growth factor receptor 1)FGFR2 (Keratinocyte growth factor receptor)FGFR3 (Fibroblast growth factor receptor 3)FGFR4 (Fibroblast growth factor receptor 4)IL2RB (IL-2 receptor beta chain)KIT (c-KIT proto-oncogene receptor tyrosine kinase)PDGFRA (Platelet-derived growth factor receptor alpha)RET (Rearranged during transfection receptor tyrosine kinase)VEGFR-1 (Vascular endothelial growth factor receptor 1)VEGFR2 (Vascular endothelial growth factor receptor 2)VEGFR4 (Vascular endothelial growth factor Receptor-3)CD80 (T-lymphocyte activation antigen CD80)
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